Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring

• Sponsor: Myovant Sciences GmbH (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05739123
• Collaborator: (none)
• Enrollment: 728
• Anticipated Duration (Months): 122.9

Study Details

Study Description

Brief Summary

The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related; Pregnancy Complications; Pregnancy, High Risk	Drug: Relugolix-Containing Product

Detailed Description

The outcomes of interest include major congenital malformation (MCM; primary outcome), minor congenital malformation, spontaneous abortion (SAB), stillbirth, elective termination, small for gestational age (SGA), preterm birth, postnatal growth deficiency, and infant developmental deficiency.

Pregnancy outcomes will be assessed throughout pregnancy, with data collection occurring at enrollment, the end of the second trimester, and pregnancy outcome. Infant outcomes will be assessed throughout the infant's first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery. Enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable, will serve as data reporters to the registry.

The registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are documented in patients' medical records during the course of medical care will be collected. No additional laboratory tests or HCP assessments will be required as part of this registry.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 728 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: May 1, 2033
• Anticipated Study Completion Date: May 1, 2033

Arms and Interventions

Arm	Intervention/Treatment
Exposed Cohort Pregnant women who are exposed to relugolix-containing therapy at any time during pregnancy	Drug: Relugolix-Containing Product; Any relugolix-containing therapy; Other Names: TAK-385 T-1331285 RVT-601 MVT-601 MVT-601A MYFEMBREE
Unexposed Cohort Pregnant women with conditions for which relugolix-containing therapy may be prescribed for indications that are approved or under phase 3 development and who are not exposed to relugolix-containing therapy at any time during pregnancy

Outcome Measures

Primary Outcome Measures

1. Major Congenital Malformation (MCM) [Up to 10 years]

   Comparison of rate of MCM between cohorts

Secondary Outcome Measures

1. Minor congenital malformations [Up to 10 years]

   Comparison of rate of minor congenital malformations between cohorts

2. Spontaneous abortion (SAB) [Up to 10 years]

   Comparison of rate of SABs between cohorts

3. Stillbirth [Up to 10 years]

   Comparison of rate of stillbirths between cohorts

4. Elective termination [Up to 10 years]

   Comparison of rate of elective terminations between cohorts

5. Preterm birth [Up to 10 years]

   Comparison of rate of preterm births between cohorts

6. Small for gestational age (SGA) [Up to 10 years]

   Comparison of rate of SGA between cohorts

7. Postnatal growth deficiency [Up to 10 years]

   Comparison of rate of postnatal growth deficiency between cohorts

8. Infant developmental deficiency [Up to 10 years]

   Comparison of rate of infant developmental deficiency between cohorts

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Woman of any age

• Currently or recently pregnant

• Consent to participate

• Authorization for her HCP(s) to provide data to the registry

Cohort 1

• Exposure to at least one dose of relugolix-containing therapy at any time during pregnancy

Cohort 2

• Diagnosis of a condition for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix containing therapy at any time during pregnancy

Exclusion Criteria:

The following will be eligible for enrollment, included in supplementary analyses, but excluded from the analysis population:

• Occurrence of pregnancy outcome prior to first contact with the RCC (retrospectively enrolled)

• Exposure to known teratogens and/or investigational medications during pregnancy

• Lost to follow-up

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Myovant Sciences GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Myovant Sciences GmbH
• ClinicalTrials.gov Identifier: NCT05739123
• Other Study ID Numbers: MVT-601A-002
• First Posted: Feb 22, 2023
• Last Update Posted: Feb 22, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Myovant Sciences GmbH: Relugolix; Uterine Fibroids; Endometriosis; Pregnancy
• Additional relevant MeSH terms: Pregnancy Complications; Relugolix

Study Results

No Results Posted as of Feb 22, 2023